KR102466348B1 - 면역억제제 제제 - Google Patents

면역억제제 제제 Download PDF

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KR102466348B1
KR102466348B1 KR1020167027528A KR20167027528A KR102466348B1 KR 102466348 B1 KR102466348 B1 KR 102466348B1 KR 1020167027528 A KR1020167027528 A KR 1020167027528A KR 20167027528 A KR20167027528 A KR 20167027528A KR 102466348 B1 KR102466348 B1 KR 102466348B1
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dosage form
siphonimod
moisture
lubricant
mixture
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Korean (ko)
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KR20160144366A (ko
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필립 미셀 렌 부이요
에메릭 레이노
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노파르티스 아게
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/397—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having four-membered rings, e.g. azetidine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2886—Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5089—Processes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Pain & Pain Management (AREA)
  • Transplantation (AREA)
  • Rheumatology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Nitrogen And Oxygen Or Sulfur-Condensed Heterocyclic Ring Systems (AREA)
KR1020167027528A 2014-04-10 2015-04-08 면역억제제 제제 Active KR102466348B1 (ko)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201461977806P 2014-04-10 2014-04-10
US61/977,806 2014-04-10
PCT/IB2015/052552 WO2015155711A1 (en) 2014-04-10 2015-04-08 Immunosuppressant formulation

Publications (2)

Publication Number Publication Date
KR20160144366A KR20160144366A (ko) 2016-12-16
KR102466348B1 true KR102466348B1 (ko) 2022-11-10

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KR1020167027528A Active KR102466348B1 (ko) 2014-04-10 2015-04-08 면역억제제 제제

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US (5) US20170027906A1 (enExample)
EP (1) EP3129006B1 (enExample)
JP (2) JP6679495B2 (enExample)
KR (1) KR102466348B1 (enExample)
CN (1) CN106163502B (enExample)
AR (1) AR100002A1 (enExample)
AU (1) AU2015246038C1 (enExample)
CA (1) CA2942236C (enExample)
CL (1) CL2016002560A1 (enExample)
DK (1) DK3129006T3 (enExample)
EA (1) EA201692043A1 (enExample)
ES (1) ES2865451T3 (enExample)
HU (1) HUE054245T2 (enExample)
IL (1) IL247599B (enExample)
MX (1) MX2016013236A (enExample)
PE (1) PE20161385A1 (enExample)
PH (1) PH12016501841A1 (enExample)
PL (1) PL3129006T3 (enExample)
PT (1) PT3129006T (enExample)
SG (1) SG11201607354PA (enExample)
SI (1) SI3129006T1 (enExample)
TW (1) TW201622707A (enExample)
WO (1) WO2015155711A1 (enExample)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SG191286A1 (en) 2011-01-07 2013-07-31 Novartis Ag Immunosuppressant formulations
KR102466348B1 (ko) * 2014-04-10 2022-11-10 노파르티스 아게 면역억제제 제제
US11434200B2 (en) 2017-03-09 2022-09-06 Novartis Ag Solid forms comprising an oxime ether compound and a coformer, compositions and methods of use thereof
US11629124B2 (en) 2017-03-09 2023-04-18 Novartis Ag Solid forms comprising an oxime ether compound, compositions and methods of use thereof
ES3024636T3 (en) 2017-09-27 2025-06-04 Novartis Ag Parenteral formulation comprising siponimod
AU2018343239A1 (en) 2017-09-29 2020-03-12 Novartis Ag Dosing regimen of siponimod
WO2019064212A1 (en) 2017-09-29 2019-04-04 Novartis Ag DOSAGE DIAGRAM OF SIPONIMOD
US11673860B2 (en) 2018-01-22 2023-06-13 Teva Pharmaceuticals International Gmbh Crystalline siponimod fumaric acid and polymorphs thereof
CN109908095A (zh) * 2019-04-08 2019-06-21 肇庆学院 一种西尼莫德片剂及制备方法
WO2021214717A1 (en) 2020-04-23 2021-10-28 Novartis Ag Dosing regimen for the use of siponimod for the treatment of acute respiratory distress syndrome
CN113633632A (zh) * 2021-09-09 2021-11-12 暨南大学附属第一医院（广州华侨医院） siponimod在制备抗肿瘤转移药物中的应用
US20260207513A1 (en) 2022-12-12 2026-07-23 Synthon B.V. Pharmaceutical composition of siponimod

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012095853A1 (en) 2011-01-10 2012-07-19 Novartis Pharma Ag Modified release formulations comprising sip receptor modulators

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009048993A2 (en) * 2007-10-12 2009-04-16 Novartis Ag Compositions comprising sphingosine 1 phosphate (s1p) receptor modulators
JP5190815B2 (ja) 2008-07-16 2013-04-24 日本電気株式会社 Ｉｕ−ＵＰプロトコルのネゴシエーション結果情報の通知方法、プロトコル変換方法、通信ネットワークシステム、インターワーキング装置、ＩｕＵＰネゴシエーション結果情報取得装置及びコンピュータ読み取り可能な情報記録媒体
AU2009327405A1 (en) 2008-12-18 2011-06-30 Novartis Ag New polymorphic form of 1- (4- { l- [ (E) -4-cyclohexyl--3-trifluoromethyl-benzyloxyimino] -ethyl) -2-ethyl-benzy l) -azetidine-3-carboxylic
HRP20131106T1 (hr) 2008-12-18 2013-12-20 Novartis Ag Hemifumaratna sol od 1-[4-[1-(4-cikloheksil-3-trifluorometil-benziloksiimino)-etil]-2-etil-benzil]-azetidin-3-karboksilne kiseline
MX367667B (es) * 2008-12-22 2019-08-30 Novartis Ag Régimen de dosificación de un agonista de los receptores de s1p.
CN101480374A (zh) * 2009-01-20 2009-07-15 苏州中化药品工业有限公司 一种稳定的固体药物组合物
SG191286A1 (en) * 2011-01-07 2013-07-31 Novartis Ag Immunosuppressant formulations
KR102466348B1 (ko) * 2014-04-10 2022-11-10 노파르티스 아게 면역억제제 제제

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012095853A1 (en) 2011-01-10 2012-07-19 Novartis Pharma Ag Modified release formulations comprising sip receptor modulators

Also Published As

Publication number Publication date
DK3129006T3 (da) 2021-04-19
SG11201607354PA (en) 2016-10-28
US20190328705A1 (en) 2019-10-31
US20170027906A1 (en) 2017-02-02
CL2016002560A1 (es) 2017-04-07
SI3129006T1 (sl) 2021-08-31
IL247599B (en) 2020-08-31
IL247599A0 (en) 2016-11-30
EP3129006A1 (en) 2017-02-15
US20250073203A1 (en) 2025-03-06
HUE054245T2 (hu) 2021-08-30
KR20160144366A (ko) 2016-12-16
AU2015246038B2 (en) 2017-11-30
JP2020097591A (ja) 2020-06-25
JP2017510602A (ja) 2017-04-13
MX2016013236A (es) 2017-01-16
WO2015155711A4 (en) 2015-12-10
CA2942236C (en) 2023-08-29
CN106163502B (zh) 2020-12-01
ES2865451T3 (es) 2021-10-15
AU2015246038A1 (en) 2016-09-22
PE20161385A1 (es) 2017-01-05
TW201622707A (zh) 2016-07-01
EP3129006B1 (en) 2021-01-27
US20180207128A1 (en) 2018-07-26
PH12016501841A1 (en) 2017-01-09
AR100002A1 (es) 2016-08-31
WO2015155711A1 (en) 2015-10-15
PT3129006T (pt) 2021-04-09
AU2015246038C1 (en) 2018-05-31
CA2942236A1 (en) 2015-10-15
CN106163502A (zh) 2016-11-23
PL3129006T3 (pl) 2021-07-05
US20210161860A1 (en) 2021-06-03
EA201692043A1 (ru) 2017-02-28
JP6679495B2 (ja) 2020-04-15

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